Benefits of a Cognitive Behavioral Therapy Intervention for Smoking Cessation Supported by Virtual Reality Smoking Cue Exposure (ViReTa)

University Hospital Tuebingen

Status: Completed

Conditions: Smoking Cessation

Treatments: Behavioral: progressive muscle relaxation; Behavioral: virtual reality based cue exposure; Behavioral: CBT smoking cessation

Study type: Interventional

Funder types: Other

Identifiers

NCT03707106

70111871

Details and patient eligibility

About

Cognitive-behavioral therapy (CBT) combined with medication is an established intervention for smoking cessation. However, long-term abstinence rates of maximum 35% are yielded. Moreover, acceptance of drug treatment is partly very low. Professional recommendation of drug treatment besides nicotine-replacement aids is restrained considering side effects and contraindications. Currently, cue exposure is highly discussed as intervention for craving reduction supporting CBT. There is evidence for benefits of cue exposure optimizing smoking cessation outcomes, as well as evidence for efficacy of exposure in virtual reality (VR) up to date.

However, this is the first randomized controlled study focusing on efficacy increases by VR cue exposure supporting an established CBT smoking cessation manual. The control group receives a specific stress reduction treatment (independent of smoking cues), namely, the Progressive Muscle Relaxation (PMR, according to Jacobson) additionally to the established smoking cessation CBT.

Enrollment: 246 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• daily smokers for at least 2 years, smoking minimum 10 cigarettes a day

Exclusion criteria

• pregnancy
• current participation in another smoking cessation program within 6 months before assignment
• current diagnosis of a psychiatric disease including a depression or substance use disorder (excluding nicotine dependency)
• lifetime diagnosis of a psychiatric disease : psychosis, bipolar affective disorder, posttraumatic stress disorder, conversion disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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246 participants in 2 patient groups

VR based cue exposure smoking cessation

Experimental group

Description:

an established CBT intervention for smoking cessation supported by cue exposure in virtual reality

Treatment:

Behavioral: CBT smoking cessation

Behavioral: virtual reality based cue exposure

PMR supported smoking cessation

Active Comparator group

Description:

an established CBT intervention for smoking cessation supported supported by specific stress reduction (Progressive Muscle Relaxation, Jacobson)

Treatment:

Behavioral: progressive muscle relaxation

Behavioral: CBT smoking cessation